Boehringer Ingelheim press release on Pradaxa: ruled unbalanced for omitting bleeding risk (AUTH/2403/5/11)

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Key facts

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Case	AUTH/2403/5/11
Complainant	General practitioner
Company	Boehringer Ingelheim Limited
Medicine	Pradaxa (dabigatran)
Context	Daily Mail article (5 April 2011) prompted by ACC 2011-related press activity; Panel assessed company press materials rather than the article itself
Key issue upheld	Press release not balanced because it omitted comparative bleeding risk information
Breach clauses	22.2
Non-breach clauses considered	8.1, 22.1, 9.1, 9.2, 2
Complaint received	05 May 2011
Case completed	20 July 2011
Appeal	No appeal
Sanction	Undertaking received
Applicable Code year	2011

Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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A general practitioner complained about a Daily Mail article (5 April 2011) about Pradaxa (dabigatran).
The article described warfarin as “rat poison” and called Pradaxa a “wonder drug”; it also used an image the complainant considered sexualised and inappropriate.
Because press complaints are judged on what the company (or its agent) provided to journalists, the Panel assessed Boehringer Ingelheim’s certified press release supplied to the journalist (and related materials), not the newspaper copy itself.
The press release (issued around the ACC 2011 conference) presented subgroup analyses from the RE-LY programme in atrial fibrillation, including comparative stroke outcomes vs well-controlled warfarin.
The press release included relative stroke risk reductions for dabigatran 150mg vs warfarin across AF types, but did not mention major haemorrhage/bleeding risk in the comparison.

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Breach of Clause 22.2 (information to the public must be factual and balanced): omission of comparative bleeding risk meant the press release was not balanced.
No breach of Clause 8.1 (disparagement): the press release did not call warfarin “rat poison” and only referenced warfarin as a comparator; no evidence BI spokespersons used disparaging language.
No breach of Clause 22.1 (advertising POMs to the public): despite very positive “Notes to Editors” wording, the Panel did not consider the press release constituted an advertisement to the public.
No breach of Clauses 9.1 and 9.2 (suitability/taste): BI and its agency did not provide the image used by the Daily Mail.
No breach of Clause 2 (bringing discredit): the Panel did not consider the press release reduced confidence in the industry.
No appeal.

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